XTalks

JULY 14, 2022

Related: Vtama (tapinarof) Cream Gains FDA Approval for the Treatment of Plaque Psoriasis in Adults. The company has partnered with the likes of HemoShear Therapeutics to discover new gout therapies, as well as Arrowhead Pharmaceuticals to develop an RNA interference (RNAi) therapeutic for the disease.

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pharmaphorum

NOVEMBER 24, 2020

The FDA has approved Alnylam’s gene silencing drug Oxlumo, the first treatment for primary hyperoxaluria type 1 (PH1), an ultra-rare and life-threatening genetic disorder. The Swiss pharma’s bet looks to have paid off as inclisiran is likely to be approved in Europe in the coming weeks after backing from CHMP regulators last month.

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XTalks

JANUARY 9, 2023

log10 copies/mL reduction in HIV-1 RNA from baseline at the end of the functional monotherapy period. Thirty-six participants were randomly allocated to receive either oral lenacapavir or placebo in a 2:1 ratio for 14 days, while continuing their failing regimen (functional monotherapy).

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XTalks

AUGUST 18, 2020

An important feature of the test that contributes to its reduced cost is the fact that sample processing does not require a separate nucleic acid (RNA) extraction step. This is significant because shortages of RNA extraction kits have been a recurrent issue since the beginning of the pandemic. And now it’s getting approval.

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The Pharma Data

JANUARY 21, 2021

Today’s FDA approval of Cabenuva represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care,” said Lynn Baxter, Head of North America, ViiV Healthcare. “Not At the same time, the FDA approved ViiV’s New Drug Application (NDA) for Vocabria (cabotegravir) 30 mg oral tablets.

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The Pharma Data

FEBRUARY 25, 2022

Several FDA-approved drugs – including for type 2 diabetes, hepatitis C and HIV – significantly reduce the ability of the Delta variant of SARS-CoV-2 to replicate in human cells, according to new research led by scientists at Penn State. ” The findings published today (Feb.

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FDA Approval Drugs Protein In-Vitro 52

XTalks

JANUARY 25, 2021

Patients in the studies were virologically suppressed (HIV-1 RNA less than 50 copies/milliliter) prior to initiation of treatment with Cabenuva. Cabenuva was actually expected to win FDA approval towards the end of 2019; however, manufacturing issues garnered rejection from the FDA at the time. Opening up Options.

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The Pharma Data

JANUARY 22, 2021

Approval was based on data from the Phase 3 ATLAS and FLAIR studies, two randomized, open-label, controlled clinical trials in 1,182 HIV-infected adults. Before initiating Cabenuva treatment, study participants were virologically suppressed (HIV-1 RNA <50 copies/mL).

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FDA Approval RNA Clinical Trials Clinical Trials 52

XTalks

NOVEMBER 30, 2023

New FDA-Approved Treatments For HIV HIV treatment involves the administration of combined antiretroviral therapy (ART) to effectively suppress the viral load, maintain or enhance immune function and reduce the risk of opportunistic infections and cancers commonly associated with HIV. aiming to end the HIV epidemic by 2030.

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The Pharma Data

NOVEMBER 18, 2020

Food and Drug Administration has said that coronavirus vaccines should be at least 50 percent effective to be approved. Both vaccine makers used a synthetic version of coronavirus genetic material called messenger RNA to program a person’s cells to churn out copies of a fragment of the virus, the Times said.

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XTalks

OCTOBER 7, 2020

While the new test is based on RT-PCR molecular detection, it utilizes a high-throughput technique involving a new heat-based extraction method and enhanced technology to extract RNA from samples for COVID-19 testing. LabCorp was given the green light for the test by the FDA last week, which is set to be rolled out soon.

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XTalks

MAY 10, 2023

In this episode, Ayesha talked about the FDA approval of the world’s first vaccine for respiratory syncytial virus (RSV). The vaccine is approved for adults 60 years of age and older. Ayesha and the team also discussed the FDA approval of Qalsody (tofersen), a novel, first-of-its-kind treatment for ALS.

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Life Science Vaccination Vaccine FDA Approval 52

XTalks

JUNE 14, 2023

More Drugs for Dry Eye Disease Are on the Way Several other drugs have recently gained FDA approval or are currently in advanced stages of clinical development for the treatment of dry eye disease. One such approved medication is Miebo , an ophthalmic solution developed by Bausch + Lomb and Novaliq.

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Drug Discovery World

DECEMBER 21, 2023

A Nature publication confirmed that there are currently 12 FDA-approved ADCs on the market, and nine of these secured FDA approval in the past six years. DDW Multimedia Editor Megan Thomas explored three trends in the market. Read the article: Where are the hottest drug discovery hubs in the US?

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Gene Therapy Gene Antibody FDA Approval 59

Drug Discovery World

AUGUST 9, 2023

The new acquisition gives Biogen rights to Reata’s portfolio of products for neurological diseases, including the FDA-approved Skyclarys (omaveloxolone), the only approved treatment for Friedreich’s ataxia (FA) in the United States.

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Drug Discovery World

JUNE 14, 2023

An FDA approval for Pfizer’s Abrysvo respiratory syncytial virus (RSV) vaccine is likely to threaten GSK’s current hold on the market, according to GlobalData. As an RNA virus, RSV is capable of rapid mutation to escape attack by new pharmaceuticals.

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pharmaphorum

DECEMBER 23, 2021

At its second attempt, Novartis has won FDA approval for its cholesterol lowering drug inclisiran, which can reduce levels with just two injections a year. Novartis resubmitted its marketing application in the US earlier this year, after swapping fill-and-finish production to one of its own facilities in Schaftenau, Austria.

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XTalks

NOVEMBER 7, 2022

Immunofluorescent staining of CTCs is a CTC isolation method that has been used since the first US Food and Drug Administration (FDA) approval in 2013 for the CellSearch ® CTC enumeration platform. Regulatory Approvals for CTC-Based Assays in Oncology. Table 1: Some examples of cfDNA-based assays that are approved by the US FDA.

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Drug Discovery World

AUGUST 1, 2023

1 August was first chosen as World RNA Day in 2018 as a play on AUG (adenine, uracil and guanine), a triple sequence of RNA (called a codon) that initiates protein synthesis by the cell. Since then, it has been observed to publicise the importance of this molecule in the generation of proteins in the body.

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pharmaphorum

APRIL 5, 2022

.” Strong efficacy data is likely to be the key to carving out a role for the antisense drug in the PCSK9 inhibitor class, particularly as it is up against some heavyweight competition – notably Novartis’ small interfering RNA (siRNA) therapy Leqvio (inclisiran), which only needs to be administered twice a year.

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Roots Analysis

DECEMBER 18, 2023

In 2018, the French-based Advanced Accelerator Applications, a subsidiary of Novartis, achieved a significant milestone by obtaining the FDA approval for its product Lutathera®, a next-generation drug conjugate designed for GEP-NET (Gastroenteropancreatic Neuroendocrine Tumors).

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The Pharma Data

DECEMBER 8, 2020

Laying down a new track for RNA processing, Remix launched with $81 million in financing. Funds will be used to support development of the REMaster technology platform and advance the company’s pipeline of RNA processing targeted therapeutics as well. “As Pear Therapeutics.

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RNA Antibody Life Science Protein 52

pharmaphorum

JULY 19, 2021

Drugs harnessing the potential of modified RNA, antisense and siRNA oligonucleotides, antibody–drug conjugates and nanomedicines will become as important as today’s ‘small molecule’ drugs, reaching potential market values into the hundreds of billions – if the potential can be realised through innovation support and industry collaboration.

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Drug Discovery World

SEPTEMBER 14, 2023

Moreover, in July 2023, AstraZeneca and Vaxess Technologies commenced a collaboration for the evaluation of a novel RNA-based pandemic influenza prototype vaccine in patch format. Moreover, the FDA approved Pfizer’s Elrexfio (elranatamab-bcmm) for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM).

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The Pharma Data

JANUARY 31, 2021

Similar to other enveloped RNA viruses such as HIV, RSV and Influenza, SARS-CoV-2 is also an RNA virus that has a trimeric spike (S) protein on its viral envelope. FDA approval for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

XTalks

AUGUST 12, 2020

Related: FDA Approves Rukobia for HIV Patients with Limited Treatment Options. Studies have identified the presence of two types of HIV-infected CD4+ T cells: ‘Transcriptionally inactive’ cells that do not typically produce viral RNA or viral proteins.

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The Pharma Data

DECEMBER 16, 2020

To this point, Moderna has only submitted two months of follow-up safety data, and the FDA typically requires six months for a full approval. intends to ship just shy of six million doses of Moderna’s vaccine once the FDA approves EUA. Initial doses are expected to be limited as manufacturing ramps up.

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The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) approved VAXNEUVANCE ™ (Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older.

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Immune Response Vaccination Vaccine FDA Approval 52

XTalks

DECEMBER 22, 2021

The RNA Revolution: From mRNA Vaccines to RNA Editing. The age of RNA is officially here, and it’s here to stay as more than a passing life science trend. RNA technology is not new nor has its potential been surprising. RNA in the Making. So why did this perceived RNA ‘revolution’ take so long?

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The Pharma Data

JANUARY 21, 2021

In the ATLAS study, CABENUVA met the primary endpoint for noninferiority (the proportion of participants with plasma HIV-1 RNA ?50 50 copies per milliliter [c/mL] at Week 48), with a comparable number of patients receiving either CABENUVA or their daily current antiretroviral regimen (CAR) having an HIV-1 RNA level ?50

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The Pharma Data

NOVEMBER 24, 2020

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1. Food and Drug Administration (FDA) approved Oxlumo (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.

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The Pharma Data

DECEMBER 3, 2020

Similar to other enveloped RNA viruses such as HIV, RSV and Influenza, SARS-CoV-2 is also an RNA virus that has a trimeric spike (S) protein on its viral envelope. FDA approval for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

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Vaccination Vaccine Immune Response Protein 52

pharmaphorum

DECEMBER 23, 2022

Gilead Sciences has claimed FDA approval for Sunlenca, a therapy from Gilead Sciences for people with multidrug-resistant (MDR) HIV infection that only needs to be taken twice a year, at the second time of asking. The post FDA approves twice-yearly resistant HIV therapy from Gilead appeared first on.

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The Pharma Data

NOVEMBER 16, 2020

It combines Moderna’s mRNA (messenger RNA) delivery platform with the stabilized SARS-CoV-2 spike immunogen (S-2P) developed by NIAID scientists. To date, BARDA-supported products have achieved 55 FDA approvals, licensures or clearances. MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History. Source: NIH.

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Clinical Trials Clinical Trials Vaccination Vaccine 52

pharmaphorum

DECEMBER 23, 2020

There was some steady progress in neurology – in February FDA approved Lundbeck’s eptinezumab prophylactic treatment for migraine, the last from a gang of four drugs from a new class. It was the third approval from Alnylam’s pipeline of RNA interference therapeutics to make it to market. months, compared with 6.7

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Drug Discovery World

MARCH 7, 2023

Prior to Twist Bioscience, she worked at Agilent Technologies and at the University of Houston developing DNA and RNA parallel synthesis processes on solid support. She has published over 30 peer-reviewed papers.

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XTalks

JUNE 5, 2023

RSV belongs to the family of negative-strand RNA viruses and was first identified in 1955. Today’s FDA approval of Abrysvo recognizes significant scientific progress, and importantly helps provide older adults potential protection against RSV and an opportunity to improve community health by helping prevent the disease,” said Edward E.

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